SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0159-055-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
OraQuick HIV 1/2 Rapid Antibody Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
OraSure Technologies, Inc.
220 East First Street
Bethlehem,
18015
United States of America
Pathogen
HIV
Specimen Type
Oral fluid
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
5x4-0010
Test kit package size
100
Identification name
5x4-0012
Test kit package size
500
Identification name
5x4-0014
Test kit package size
100
Test Package Size
100 x Pouch containing 1 test device, 1
desiccant, 1 developer solution vial
containing 1ml of phosphate buffer
saline solution containing polymers
and an antimicrobial agent, 10 x Test stands, 5 x Specimen collection loops, 1 x IFU
desiccant, 1 developer solution vial
containing 1ml of phosphate buffer
saline solution containing polymers
and an antimicrobial agent, 10 x Test stands, 5 x Specimen collection loops, 1 x IFU
Identification name
5X4-0062
Test kit package size
100
Test Package Size
100 x Pouch containing 1 test device, 1
desiccant, 1 developer solution vial
containing 1ml of phosphate buffer
saline solution containing polymers
and an antimicrobial agent, 10 x Test stands, and 3 x IFUs
desiccant, 1 developer solution vial
containing 1ml of phosphate buffer
saline solution containing polymers
and an antimicrobial agent, 10 x Test stands, and 3 x IFUs
Identification name
5x4-0015
Test kit package size
500
Test Package Size
500 x Pouch containing 1 test device, 1
desiccant, 1 developer solution vial
containing 1ml of phosphate buffer
saline solution containing polymers
and an antimicrobial agent, 20 x Test stands, 25 x Specimen collection loops, and 1 x IFU
desiccant, 1 developer solution vial
containing 1ml of phosphate buffer
saline solution containing polymers
and an antimicrobial agent, 20 x Test stands, 25 x Specimen collection loops, and 1 x IFU
IVD Manufacturing Site(s)
OraSure Technologies - North Facility
1745 Eaton Ave
Bethlehem,
18015
United States of America
Pacific Biotech Co., Ltd_site 1
42 Moo 4, Chailanglub Rd, Napa
Muang, Petchaboon,
6700
OraSure Technologies - Tech III Facility
220 E First Street
Bethlehem,
18015
United States of America
Orasure Technologies - South Facility
150 Webster Street
Bethlehem,
18015
United States of America